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临床试验/NCT07587073
NCT07587073尚未招募不适用

A Pragmatic Cluster-Randomized Evaluation of Enhanced Care Management With Community Supports, Transitional Care, and Residential Care Coordination for High-Risk Medi-Cal Members Under CalAIM in California

StratiHealth1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2026年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,200
试验地点
1

研究概览

简要总结

This pragmatic, cluster-randomized trial will evaluate whether a comprehensive CalAIM-aligned care model consisting of Enhanced Care Management, selected Community Supports, Transitional Care Services, and residential care coordination improves population health outcomes among high-risk Medi-Cal managed care members in California compared with usual CalAIM service delivery. The intervention is intended to improve continuity of care after discharge, reduce potentially avoidable utilization, increase successful linkage to outpatient and social supports, and improve community tenure and patient-reported outcomes.

详细描述

California Advancing and Innovating Medi-Cal (CalAIM) initiative emphasizes person-centered care, integration across medical and social services, and support for members with complex clinical and social needs. Within this framework, Enhanced Care Management provides high-touch community-based care management, while Population Health Management requires Transitional Care Services to support members through discharge and follow-up. Community Supports may include medically appropriate substitute services such as recuperative care, short-term post-hospitalization housing, and supports related to nursing facility transition or diversion to assisted living and other community settings (Source: Department of Health Care Service (DHCS) Population Health Management (PHM) Policy Guide, DHCS Transitional Care Services (TCS) for Medi-Cal Members with Long-Term Services and Supports (LTSS) Resource, DHCS Community Supports Fact Sheet).

The study will prospectively compare two implementation approaches at the cluster level. Clusters assigned to the intervention will deliver a structured, comprehensive care bundle, including an assigned Enhanced Care Management (ECM) care manager, a discharge-transition workflow, medication-reconciliation support, timely ambulatory follow-up, community-support referral and activation, and residential stabilization or transition coordination, where indicated. Control clusters will continue usual CalAIM operations without the enhanced standardized bundle. The hypothesis is that comprehensive integration of these elements will reduce 30-day readmissions and emergency department utilization while improving community stability and total cost of care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult Medi-Cal managed care member in California.
  • Identified as high-risk for poor outcomes based on plan stratification or qualifying CalAIM criteria.
  • Eligible for ECM and at least one of the following: Transitional Care Services, Community Supports related to post-acute recovery, housing/residential stabilization, or nursing facility transition/diversion.
  • Recent discharge or active transition from hospital, emergency department, skilled nursing facility, post-acute facility, recuperative care, assisted living, residential behavioral health setting, or other qualifying level-of-care transition.
  • Able to provide informed consent, or eligible for waiver/alteration of consent if approved for cluster-level pragmatic implementation research.

排除标准

  • Enrollment in hospice or expected survival less than 6 months at the time of the index episode.
  • Long-term custodial institutional placement without an anticipated community transition plan.
  • Current incarceration or detention is preventing intervention delivery.
  • Previous enrollment in this study during the same observation window.
  • Any condition that, in the investigator's judgment, makes participation infeasible or data interpretation unreliable.

研究者

发起方
StratiHealth
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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